A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer

Jeroen Bosch Ziekenhuis5 sites in 1 country50 target enrollmentJune 2008

ConditionsGastric Cancer

DrugsDocetaxel cisplatin Capecitabine

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Gastric Cancer
Sponsor: Jeroen Bosch Ziekenhuis
Enrollment: 50
Locations: 5
Primary Endpoint: The number of patients with (serious) adverse events receiving the combination of 4 courses of docetaxel, cisplatin and capecitabine as neoadjuvant chemotherapy and standardized surgery in resectable localized or locally advanced gastric cancer.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the feasibility of chemotherapy, consisting of docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. Furthermore, an extended type of removal of lymph nodes will be implemented.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

May 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jeroen Bosch Ziekenhuis

Responsible Party

Principal Investigator

Anneriet Dassen

Ms A.E. Dassen, MD, Principle Investigator

Jeroen Bosch Ziekenhuis

Eligibility Criteria

Inclusion Criteria

•Ib-IVa histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma Siewert 2 and 3
•ASA 2 or less
•Age 18 years or more
•No prior radio- or chemotherapy conflicting with the treatment of gastric cancer
•Haematology/Renal function/Liver function within designated range
•Patient's consent form obtained, signed and dated before beginning specific protocol procedures
•absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
•before patient registration/randomization, written informed consent must be given according to GCP, WMO and local regulations.

Exclusion Criteria

•Previous or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non-melanoma skin cancer
•Other current serious illness or medical conditions
•Severe cardiac illness (NYHA class III-IV)
•Significant neurologic or psychiatric disorders
•Uncontrolled infections
•Active DIC
•Other serious underlying medical conditions that could impair the ability of the patient to participate in the study
•Known hypersensitivity to docetaxel (or any drug formulated with Polysorbate-80), or cisplatin or capecitabine or 5-FU
•Definite contraindications for the use of corticosteroids
•Use of immunosuppressive or antiviral drugs

Outcomes

Primary Outcomes

The number of patients with (serious) adverse events receiving the combination of 4 courses of docetaxel, cisplatin and capecitabine as neoadjuvant chemotherapy and standardized surgery in resectable localized or locally advanced gastric cancer.

Time Frame: 18 weeks

Patients receive every 3 weeks a cycle of chemotherapy, in total 4 cylcles will be given. Surgery will be performed approximately 6 weeks after the last cycle.